#293995
3.7.2.3. Tromachar na fianaise
3.7.2.3. Weight of evidence
3.7.2.3. Tromachar na fianaise
3.7.2.3. Weight of evidence
1.2. Tromachar na fianaise
1.2. Weight of evidence
(“Tromachar na fianaise”), cuirtear an méid seo a leanas in ionad an téacs:
(‘Weight of evidence’), the text is replaced by the following:
Tromachar na fianaise agus breithiúnas saineolaithe
Weight of evidence and expert judgment
(a) nuair nach bhfuil tromachar na fianaise ón duine cinntitheach go leor chun aicmiú i gCatagóir 1 a údarú, agus/nó
(a) when the weight of human evidence is not sufficiently convincing to warrant Category 1 classification, and/or
(a) nuair nach bhfuil tromachar na fianaise ón duine cinntitheach go leor chun aicmiú i gCatagóir 1 a údarú;
(a) when the weight of human evidence is not sufficiently convincing to warrant Category 1 classification;
Baineann na hathruithe sin go háirithe le forálacha maidir le húsáid na sonraí atá ann cheana, tromachar na fianaise agus grúpáil na substaintí.
Those changes concern, in particular, the provisions on use of existing data, weight of evidence and grouping of substances.
3.6.2.1. Chun críocha a n-aicmithe ó thaobh carcanaigineachta, déantar substaintí a leithdháileadh ar cheann amháin de dhá chatagóir bunaithe ar neart na fianaise agus ar thosca eile (tromachar na fianaise).
3.6.2.1. For the purpose of classification for carcinogenicity, substances are allocated to one of two categories based on strength of evidence and additional considerations (weight of evidence).
Déanfar na héifeachtaí díobhálacha sa suth nó san fhéatas a mheas ar dtús, agus ansin tocsaineacht mháthar, chomh maith le tosca ar bith eile ar dócha go raibh tionchar acu ar na héifeachtaí seo, amhail tromachar na fianaise, chun cuidiú le teacht ar chonclúid maidir le haicmiú.
The adverse effects in the embryo/foetus shall be first considered, and then maternal toxicity, along with any other factors which are likely to have influenced these effects, as weight of evidence, to help reach a conclusion about classification.
3.8.2.1.4. Úsáidtear tromachar na fianaise maidir leis na sonraí uile (féach roinn 1.1.1), lena n-áirítear teagmhais dhaonna, eipidéimeolaíocht agus staidéir a rinneadh in ainmhithe turgnamhacha, chun tacú le héifeachtaí tocsaineacha sain-spriocorgáin a thuilleann aicmiú.
3.8.2.1.4. Weight of evidence of all data (see section 1.1.1), including human incidents, epidemiology, and studies conducted in experimental animals, is used to substantiate specific target organ toxic effects that merit classification.
3.9.2.4. Úsáidtear tromachar na fianaise maidir leis na sonraí uile (féach roinn 1.1.1), lena n-áirítear teagmhais dhaonna, eipidéimeolaíocht agus staidéir a rinneadh in ainmhithe turgnamhacha, chun bonn a thabhairt d’éifeachtaí tocsaineacha sain-spriocorgáin a thuilleann aicmiú.
3.9.2.4. Weight of evidence of all data (see section 1.1.1), including human incidents, epidemiology, and studies conducted in experimental animals, is used to substantiate specific target organ toxic effects that merit classification.
(b) Déanfar tagairtí in ailt 7 (fógra faoi fhianaise dhoiciméadach le seirbheáil ar an gcúisí), 8 (glacadh agus tromachar na fianaise doiciméadaí) agus 9 (inghlacthacht fianaise maidir le creidiúnacht sholáthróir na faisnéise) den Acht um Fhianaise Choiriúil, 1992, do dhoiciméad nó d’fhaisnéis atá i ndoiciméad a fhorléiriú mar thagairtí a fholaíonn tagairtí do dhoiciméad a luaitear i mír (a) agus don fhaisnéis atá ann, agus beidh feidhm dá réir ag na forálacha sin fara aon mhodhnuithe is gá.
(b) References in sections 7 (notice of documentary evidence to be served on accused), 8 (admission and weight of documentary evidence) and 9 (admissibility of evidence as to credibility of supplier of information) of the Criminal Evidence Act, 1992, to a document or information contained in it shall be construed as including references to a document mentioned in paragraph (a) and the information contained in it, and those provisions shall have effect accordingly with any necessary modifications.
In Iarscríbhinn XI a ghabhann le Rialachán (CE) Uimh. 1907/2006, ba cheart soiléiriú a dhéanamh ar an mbealach is féidir oiriúnú “tromachar na fianaise” a chur i bhfeidhm maidir le ceanglais faisnéise shonracha agus ar an mbealach ar cheart é a dhoiciméadú.
In Annex XI to Regulation (EC) No 1907/2006, it should be clarified how a ‘weight of evidence’ adaptation can be applied to specific information requirements and how it should be documented.
Cuirfear tromachar na fianaise i bhfeidhm go háirithe i gcás nach féidir na critéir a leagtar amach i ranna 4.4.2.1 agus 4.4.2.2 a chur i bhfeidhm go díreach maidir leis an bhfaisnéis atá ar fáil.
That weight of evidence shall be applied in particular where the criteria set out in Sections 4.3.2.1 and 4.3.2.2 cannot be applied directly to the available information.
Cuirfear tromachar na fianaise i bhfeidhm go háirithe i gcás nach féidir na critéir a leagtar amach i ranna 4.4.2.1 agus 4.4.2.2 a chur i bhfeidhm go díreach maidir leis an bhfaisnéis atá ar fáil.
That weight of evidence shall be applied in particular where the criteria set out in Sections 4.4.2.1 and 4.4.2.2 cannot be applied directly to the available information.